FDA Approves First Treatment for Severe Frostbite

 

Key Takeaways

• The FDA approved Aurlumyn, the first treatment for severe frostbite.

• Aurlumyn was shown to reduce the risk of amputation for adults with severe frostbite.

• Iloprost, the active ingredient in Aurlumyn, is a vasodilator that helps widen blood vessels and prevent blood clotting.

The Food and Drug Administration (FDA) has approved the first treatment for severe frostbite that can lower the chances of needing amputation of fingers or toes in adults.

Mild frostbite usually heals on its own. However, if it progresses to severe frostbite—when the skin and underlying tissue are frozen and blood flow is stopped—it might require amputation.

Iloprost injection, sold under the brand name Aurlumyn, is a vasodilator that helps widen blood vessels and prevent blood clotting.

“Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes,” Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Iloprost has been used to treat severe frostbite in Europe since the 1990s. But in the United States, up until now, patients with frostbite were treated with moist heat. They may wait several days or weeks for the damaged tissues to heal and any dying or necrotic tissue—formed when tissues do not get enough blood—to separate clearly.

It’s the deep injuries from frostbite that typically call for invasive treatments, including possible amputation, according to Cheyenne Falat, MD, assistant medical director of the adult emergency department at University of Maryland Medical Center.

“These cases may have blue or gray discoloration, blood-filled blisters or black scarring, deep burning or aching pain in the joints at the time of injury, and either severe or no pain when re-warming,” Falat told Verywell. “It is difficult to determine the extent of deep tissue damage in the first few weeks after injury, so decisions regarding amputation are oftentimes delayed.”

Frostbite is an injury to body tissue caused by freezing cold temperatures, which can occur anywhere—not just on a snowy mountain, Falat said. Colder temperatures, wind chills, higher humidity and wetness, and contact with metal surfaces can increase the chances of frostbite developing.

How Effective Is Aurlumyn?

The FDA approval of Aurlumyn was based on a controlled trial consisting of 47 adults with severe frostbite. They all received aspirin by vein and standard of care. Researchers separated these patients into three groups: One group received Aurlumyn injections for six hours daily and up to eight days, while the other two received medications that were unapproved for frostbite, along with or without Aurlymyn.

Amputation was not needed in any of the patients who received iloprost injections for six hours daily and up to eight days, while some patients in the other two groups did.

What Are the Side Effects of Aurlumyn?

The main side effects of Aurlumyn are headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and low blood pressure. There’s also a warning about the possibility of experiencing symptomatic low blood pressure.

What This Mean For You

Aurlymyn is the first FDA-approved treatment for severe frostbite in adults, expected to be available in Spring 2024.